Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis

Evaluation de la Spironolactone Dans le Traitement Des choriorétinites séreuses Centrales Non résolutives à Trois Mois

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01552044

Enrollment

Registered

2012-03-13

Start date

2012-01-31

Completion date

2013-02-28

Last updated

2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Serous Chorioretinitis

Keywords

retina

Brief summary

The objective of the study is to evaluate the effect of spironolactone on 16 patients presenting with chronic non-resolutive central serous chorioretinitis (CSCR) and to evaluate whether spironolactone can resolve sub retinal fluid in these patients. CSCR is a major cause of visual loss in the young population. It is characterized by sub retinal fluid under the retina and retinal pigment epithelial detachments. The exact causes of the disease remain unknown but a choroidopathy has been suggested. Moreover, corticotherapy and stress are known risk factors of CSCR. Our preclinical studies have demonstrated that the mineralocorticoid pathway could be involved in the control of choroidal blood flow. The investigators propose to evaluate the mineralocorticoid receptors antagonist spironolactone in the treatment of CSCR. Criteria of efficacy Endpoint: reduction of subretinal fluid ≥ 40 microns Secondary endpoint: visual acuity gain ≥ 15 EDTRS letters

Detailed description

This is a prospective placebo controlled cross over study including 16 patients

Interventions

DRUGSpironolactone

25mg tablet once a day for 1 month

DRUGPlacebo

one tablet once a day for 1 month

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Patient between 18 and 60 years * CSCR affecting the macula and non-resolutive for at least 3 months * Patients having given and signed informed consent * Vital prognosis non engaged for the next 6 months.

Exclusion criteria

* Other ocular pathology * Neovascularization, * Diabetes * Uveitis * Ocular surgery in the last 3 months * Allergy to fluorescein or indocyanine green * Pregnancy or no contraception * Renal or liver insufficiency * Kaliemia ≥ 5.5 mmol/l Criteria of efficacy

Design outcomes

Primary

Measure	Time frame	Description
Change in Central macular thickness	1 and 3 months	Sub retinal fluid decrease \> or = 40 microns

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026